Neuraceq
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
30-11-2023
Charakterystyka produktu
(SPC)
30-11-2023
Sprawozdanie z oceny publicznego
(PAR)
01-07-2016
Składnik aktywny:
florbetaben (18F)
Dostępny od:
Life Molecular Imaging GmbH
Kod ATC:
V09AX06
INN (International Nazwa):
florbetaben (18F)
Grupa terapeutyczna:
Diagnostic radiopharmaceuticals
Dziedzina terapeutyczna:
Radionuclide Imaging; Alzheimer Disease
Wskazania:
This medicinal product is for diagnostic use only.Neuraceq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Neuraceq should be used in conjunction with a clinical evaluation.A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD.
Podsumowanie produktu:
Revision: 20
Status autoryzacji:
Authorised
Data autoryzacji:
2014-02-20
Ulotka dla pacjenta
30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEURACEQ 300 MBQ/ML SOLUTION FOR INJECTION
florbetaben (
18
F)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your nuclear medicine doctor
who will supervise the
procedure.
-
If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Neuraceq is and what it is used for
2.
What you need to know before Neuraceq is used
3.
How Neuraceq will be used
4.
Possible side effects
5.
How Neuraceq is stored
6.
Contents of the pack and other information
1.
WHAT NEURACEQ IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
Neuraceq contains the active substance florbetaben (
18
F).
Neuraceq is given to people with memory problems so that doctors can
perform a type of brain scan,
called a PET scan. A Neuraceq PET scan, along with other brain
function tests, can help your doctor
32
determine whether or not you may have β-amyloid plaques in your
brain. This medicine is intended
for adults only.
You should discuss the results of the test with the doctor that
requested the scan.
The use of Neuraceq does involve exposure to small amounts of
radioactivity. Your doctor and the
nuclear medicine doctor have considered that the clinical benefit of
this procedure with the
radiopharmaceutical outweighs the risk of being exposed to radiation.
2.
WHAT YOU NEED TO KNOW BEFORE NEURACEQ IS USED
NEURACEQ MUST NOT BE USED:
-
if you are allergic to florbetaben (
18
F) or any of the other ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your nuclear medicine doctor before you are given Neuraceq if
you:
-
have kidney problems
-
have liver problems
-
are pregnant or think you may be pregnant
-
are breast-feeding
CH
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Neuraceq 300 MBq/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution for injection contains 300 MBq of florbetaben (
18
F) at the date and time of
calibration.
The activity per vial ranges from 300 MBq to 3000 MBq at the date and
time of calibration.
Fluorine (
18
F) decays to stable oxygen (
18
O) with a half-life of approximately 110 minutes by emitting
a positron radiation of 634 keV, followed by photonic annihilation
radiation of 511 keV.
Excipient(s) with known effect
This medicinal product contains up to 1.2 g of ethanol and up to 33 mg
of sodium per dose (see
section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_ _
Solution for injection.
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
This medicinal product is for diagnostic use only.
Neuraceq is a radiopharmaceutical indicated for Positron Emission
Tomography (PET) imaging of
β-amyloid neuritic plaque density in the brains of adult patients
with cognitive impairment who are
being evaluated for Alzheimer’s disease (AD) and other causes of
cognitive impairment. Neuraceq
should be used in conjunction with a clinical evaluation.
A negative scan indicates sparse or no plaques, which is not
consistent with a diagnosis of AD. For the
limitations in the interpretation of a positive scan see sections 4.4
and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
A PET scan with florbetaben (
18
F) should be requested by clinicians experienced in the clinical
management of neurodegenerative disorders.
Neuraceq images should only be interpreted by readers trained in the
interpretation of PET images
with florbetaben (
18
F). A recent co-registered computed tomography (CT) scan or magnetic
resonance
(MR) imaging of the patient to get a fused PET-CT or PET-MR image is
recommended in cases of
uncertainty about the location of grey matter and of the grey/white
matter border in the PET scan (
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